Pain Relievers Use Caution

Last Editorial Review: 1/23/2004

Jan. 23, 2004: The Food and Drug Administration (FDA) has launched a national
education campaign to provide advice on the safe use of over-the-counter (OTC)
pain relief products. FDA's campaign focuses on the OTC pain and fever reducers
that contain acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs),
which include products such as aspirin, ibuprofen, naproxen sodium and
ketoprofen.

Our Comments: We applaud the FDA for its educational campaign on the
safe use of OTC products for pain. But will it help?

We are looking at a large bottle of acetaminophen. It is Tylenol. The name is
in large letters on the label. The warnings on the label are in print at most
one-sixth that size. We cannot read the warnings without our glasses and, even
with them, the warnings are not easy or inviting to read. How many people have
read the label? Have you?

Some years ago, one of us became anemic. The culprit was ibuprofen, which was
causing low-grade bleeding from the gastrointestinal tract. For arthritis we had
been taking a couple of Advil tablets up to three times a day (within the limits
on the label). What was NOT on the label what the fact that Advil can cause
stomach bleeding, particularly in senior citizens.

The FDA Commissioner Mark B. McClellan says: "We want to remind
consumers who take these products that it's important to follow current dosing
and label directions carefully."

Then, why doesn't the FDA require the warnings on the label of OTC pain
products to be legible? And why doesn't the FDA require the labels to contain
the key cautions?

We would submit that OTC pain products like Tylenol and Advil are very useful
but they can be, and often prove, to be unsafe. The FDA and the makers of these
products can help make them safer.

The Food and Drug Administration (FDA) today launched a national education
campaign to provide advice on the safe use of over-the-counter (OTC) pain relief
products.

"Pain relievers and fever reducers are safe drugs when used as directed,
but they can cause serious problems when used by people with certain conditions
or those who are taking specific medicines," said FDA Commissioner Mark B.
McClellan, M.D., Ph.D. "We want to remind consumers who take these products
that it's important to follow current dosing and label directions
carefully."

FDA's nationwide campaign focuses on the OTC pain and fever reducers that
contain acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs), which
include products such as aspirin, ibuprofen, naproxen sodium and ketoprofen.

"'Read labels carefully, be sure you are getting the proper dose, and
check with your doctor or pharmacist to be sure that you can use these drugs
safely," said Dr. McClellan.

Many OTC medicines sold for different uses have the same active ingredient.
For example, a cold-and-cough remedy may have the same active ingredient as a
headache remedy or a prescription pain-reliever. To minimize the risks of an
accidental overdose, consumers should avoid taking multiple medications that
contain the same active ingredient at the same time.

Acetaminophen is an active ingredient found in more than 600 OTC and
prescription medicines, such as pain relievers, cough suppressants and cold
medications. It is safe and effective when used correctly, but taking too much
can lead to liver damage, and even death. The risk for liver damage may be
increased in consumers who drink three or more alcoholic beverages per day while
using acetaminophen-containing medicines.

NSAIDs are common pain relievers that are also used to relieve fever and
minor aches and pains. Examples of NSAIDs are aspirin, ibuprofen, naproxen
sodium, and ketoprofen. These products can cause stomach bleeding with an
increased risk in consumers who are over 60, are taking prescription blood
thinners, are taking steroids or have a history of stomach bleeding. NSAIDS may
also increase the risk of reversible kidney problems in consumers with
preexisting kidney disease, or who are taking a diuretic (water pill).

The FDA's consumer educational campaign will include: 1) an OTC pain reliever
brochure to be distributed in pharmacies, and by health care providers, 2) a
"matte release" newspaper article to be distributed to 10,000
community papers across the country, 3) a reprint of "Use Caution With Pain
Relievers", an FDA Consumer magazine article that will be distributed at
national healthcare conferences and available for reprinting in health related
publications and 4) two print public service ads that will be sent to
approximately 100 major magazines. All of these materials are available on the
web at http://www.fda.gov/cder/drug/analgesics/default.htm.

The campaign will provide advice on how to avoid inadvertently taking more
than the recommended doses of these medicines and outline underlying health
conditions that increase risk.

In September 2002, FDA's Non-Prescription Drugs Advisory Committee
recommended changes to labeling of certain OTC drug products, including
acetaminophen and NSAIDS. They advised that these changes are needed to better
inform consumers about the ingredients in these products and possible side
effects caused by improper use. In addition to this new consumer outreach
effort, FDA will consider changing the labeling of these products to further
bolster their safe use. FDA is reviewing various changes to labeling for these
ingredients that better reflect the latest scientific knowledge about OTC oral
pain relievers.

The FDA recommends that consumers talk with healthcare professionals or
pharmacists if they have questions about using an OTC medicine and especially
before using them in combination with dietary supplements or OTC or prescription
medicines.